Department of Health and Human Services February 24, 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 27 of 27
Agency Emergency Processing Under the Office of Management and Budget Review; Draft Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice; Withdrawal
The Food and Drug Administration (FDA) is withdrawing a notice that published in the Federal Register on January 26, 2005 (70 FR 3712).
Implantation or Injectable Dosage Form New Animal Drugs; Euthanasia Solution
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Med-Pharmex, Inc. The ANADA provides for use of an injectable solution of pentobarbital sodium and phenytoin sodium for humane, painless, and rapid euthanasia of dogs.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Radioactive Drug Research Committees
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Radioactive Drug Research Committees'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Draft Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms'' dated February 2005. The draft document is intended to provide guidance to manufacturers using spore- forming microorganisms in the production of certain biological products. The draft guidance document provides recommendations to industry in response to changes made to the requirements for spore- forming microorganisms to allow greater flexibility in manufacturing.
Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps),'' dated November 2004. The guidance document provides medical device manufacturers with information about performing studies to support modifying the indication for use of communicable disease tests to include testing of cadaveric blood specimens to screen donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance document recommends a suggested protocol to modify the indication for use to include testing of cadaveric blood specimens.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; 2005 Survey of Area Agencies on Aging
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Recordkeeping and Records Access Requirements for Food Facilities
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Recordkeeping and Records Access Requirements for Food Facilities'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Application for Participation in the Medical Device Fellowship Program
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Application for Participation in the Medical Device Fellowship Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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